|Publication number||US7195610 B1|
|Application number||US 10/245,793|
|Publication date||Mar 27, 2007|
|Filing date||Sep 17, 2002|
|Priority date||Sep 17, 2001|
|Publication number||10245793, 245793, US 7195610 B1, US 7195610B1, US-B1-7195610, US7195610 B1, US7195610B1|
|Inventors||Eric J. Flachbart|
|Original Assignee||Cardinal Health 303, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (2), Referenced by (30), Classifications (11), Legal Events (6)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This patent applications claims priority of U.S. Provisional Patent Application No. 60/322,832, filed Sep. 17, 2001.
While devices have been developed for automatic control over syringe actuation, the size and power requirements of such devices suggest against their use in environments in which space is limited or external power is not readily available. Such devices have been employed for balloon inflation in various surgical procedures including the opening of strictures, or narrowings of bodily passages, such as in endoscopic dilation where a balloon is used to open an esophageal stricture. Another application is in balloon angioplasty. For example, such applications involve the use of a syringe for delivering pressurized fluid for inflating a balloon. However, in surgical settings, there tends to be minimal free space immediately proximate the surgical site, thus rendering large and complex syringe actuation devices inappropriate. Furthermore, the cost and complexity of such automatic devices make them appropriate for sequential, repeated use. Repeated use requires that the devices be cleaned, serviced, and periodically recalibrated, resulting in higher operating costs.
Without such devices, precise control over fluid dispensed from a syringe has typically required the manual manipulation of a syringe plunger by an operator. For example, a physician may apply axial pressure on a syringe plunger to force pressurized fluid into an attached balloon for inflation. Other mechanical interfaces have been proposed for coupling operator movements to the syringe piston. One example of such interfaces includes the use of threads between the plunger and the syringe barrel whereby rotation of the plunger results in a gradual axial progression (or regression) of the plunger. Reliance on human operation exposes the inflation or deflation procedure to significant variability in terms of total volume of pressure fluid dispensed, rate at which the fluid is dispensed, and susceptibility to drawback.
Consequently, there is a need for a compact and inexpensive device which can accurately control the dispensing of fluid from a syringe, particularly for balloon angioplasty applications. The compact size of the device would make it suitable for use in space-limited environments, while the lower cost would enhance its suitability for one-time or disposable use.
The presently disclosed invention pertains to a pneumatic syringe driver having a control module for regulating pressure applied to the piston of an associated syringe. The syringe driver is also adapted for receiving a canister of compressed gas such as carbon dioxide. A valve mechanism and conduits are provided in the driver for enabling the selective release of gas from the canister into a chamber, one wall of which being formed by the syringe piston. The valve mechanism and conduits also enable the selective venting of gas from the canister into the atmosphere, thereby forming a venturi which reduces the pressure in the chamber and causes the syringe piston to be withdrawn into the chamber.
An on-board battery is provided for powering the control module and the valve mechanism. A pressure sensor in communication with the control module is provided in the syringe for feedback purposes. Visual display or indicator elements are also provided in various embodiments of the invention for conveying status relative to syringe internal pressure, battery life, and/or other pertinent device information. Input elements such as pushbuttons or switches are in communication with the control module for defining the operation of the syringe driver.
One particular application of the disclosed device is for selectively inflating and deflating a balloon attached to the syringe driver in a balloon angioplasty procedure. The balloon may be attached directly or indirectly to the syringe driver.
These and other objects of the presently disclosed invention will be more fully understood by reference to the following drawing, of which:
A first embodiment of the presently disclosed pneumatic syringe driver 10 is illustrated in
The control and gas canister portion 20 includes a control module 22, an operator input interface 24, an operator output interface 26, a battery compartment (not shown), and a gas canister receptacle 28.
The control module 22 may comprise a custom integrated circuit or a digital signal processor or micro-controller with an associated and custom-programmed memory. In communication with the control module 22 and three-way valve 32 is a battery (not shown). A variety of batteries may be employed depending upon the power requirements of the active elements of the driver 10. A small form factor is beneficial, however, due to the need for overall compactness. In an alternative embodiment, a power port is provided on the driver 10 for interfacing a remote power supply to the control module 22 and the electronic three-way valve 32.
The operator input interface 24 comprises pushbuttons or switches and enables the operator to have one of several inflation routines executed by the control module 22 or to program a specific inflation regimen. The control module may respond immediately to each activation of an operator interface element, or may accumulate commands prior to be instructed to execute a programmed routine. Controls may be provided for commanding various degrees of balloon inflation, balloon inflation rate, and/or time delay between operations. Controls may also be provided for deflating the balloon according to the variables described above. In view of the applicability of the syringe driver 10 in surgical environments, it is preferred that the control interface elements be sealed and large enough to be actuated by gloved fingers.
The operator output interface 26 may comprise optical indicators such as light emitting diodes each have a predefined meaning. Alternatively, the output interface 26 may be comprised of a display screen, such as illustrated in
In a further embodiment, an electrical interface may be provided on the surface of the driver 10 and in communication with the control module for the purpose of enabling the remote programming of the inflation and deflation regimen, as well as the transmission of performance and status information to a remote terminal.
The control and gas canister portion 20 is provided in a first embodiment with a pre-installed gas canister which ahs a pierceable seal 50. In this embodiment, an element such as a threaded cap 29 is used to thrust the canister into communication with a fluid conduit 51 that pierces the canister seal. In a second embodiment with a pre-installed gas canister, the canister is already in fluid communication with the fluid conduit. In a third embodiment, the syringe driver is provided without the gas canister, and an access element such as the threaded cap 29 enables canister installation. Once again, tightening the cap 29 results in the fluid conduit piercing the canister seal.
The valve and syringe portion 30 comprises an electronic three-way valve 32 with associated fluid conduits, a syringe 44, a piston 34 dividing the syringe into a piston chamber 36 and a syringe chamber 38, a pressure sensor 40, and a balloon interface 42.
In one embodiment of the syringe driver of the present disclosure, the three-way valve 32 is an electronically driven rotary valve operating under the control of the control module 22. Alternatively, the valve may be provided as an electronically driven ball valve. Further still, the valve may be implemented through plural, independently displaceable shutters. Regardless of particular embodiment, a common requirement is that each port of the valve be gas-tight when closed.
One port of the three-way valve is in communication with the compressed gas canister once the canister is fully installed in the control and gas canister portion 20. As previously mentioned, this portion of the fluid conduit is preferably provided with a sharpened point or similar feature for piercing a seal in the compressed gas canister. A resilient seal such as an O-ring of rubber or like material may be provided in one embodiment for sealing a forward end of the gas canister to the valve and syringe portion 30 of the driver 10.
An anti-blow-by piston 34 is disposed for translation along the interior walls of the syringe 44. One side of the piston 34 forms part of the piston chamber 36, while another side of the piston 34 forms part of the syringe chamber 38. As gas pressure builds in the piston chamber relative to that in the syringe chamber, the piston moves in order to equalize the pressures. A sealing ring or rings (not shown) may also be used intermediate the piston and the syringe 44 barrel.
The syringe chamber 38 preferably contains incompressible fluid which, depending upon the specific application, may be liquid or gas. A pressure sensor 40 mounted within the syringe chamber 38 is in communication with the control module 22. Communication is preferably by way of sealed, electrically conductive wire (not shown).
While not illustrated in
The operation of the pneumatic syringe driver 10 is now described with reference to
Alternatively, if the pneumatic syringe driver 10 is provided to the user without a pre-installed compressed gas canister 28, such a canister is inserted and placed in fluid communication with the canister port of the three-way valve, such as in the manner just described.
If a balloon has not already been attached to the balloon interface 42 of the syringe driver, one is now attached, and the balloon is disposed in position for inflation as required. Alternatively, the balloon is disposed in the operating environment prior to it being attached to the syringe driver.
Through use of the operator input interface 24, a user such as a surgeon can program the device to inflate the balloon according to a desired regimen. Then, once the driver and balloon are placed in the proper position and other surgical procedures have occurred or are ready to be performed, the inflation regimen can be started.
Inflation of the balloon occurs when the control module 22 commands the three-way valve 32 to open a fluid path from the gas canister 28 to the piston chamber 36 (
Additional sequences of pressure increase in the piston chamber 36 may be affected by operation of the three-way valve until the desired balloon inflation is achieved.
Once the surgical procedure requiring balloon inflation has been completed, a certain portion of the inflation fluid pressure may be relieved by opening a fluid pathway between the piston chamber 36 and the atmosphere via the three-way valve 32. However, there may still be sufficient pressure in the syringe chamber 38 to prevent complete deflation of the balloon.
To further reduce the syringe chamber 38 pressure, all three ports of the three-way valve 32 may be placed in mutual communication by the control module 22, as in
The gas canister 28 is provided with enough pressurized gas to carry out the foregoing inflation regimen, including instances in which the attached balloon is inflated and deflated multiple times during a procedure. However, in order to minimize the size of the pneumatic syringe driver, only enough gas is provided to ensure operation for one procedure. The inexpensive electronics and battery power supply thus make the disclosed device ideal for single, disposable use.
These and other examples of the invention illustrated and described above are intended by way of example and the actual scope of the invention is to be limited solely by the scope and spirit of the following claims.
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|U.S. Classification||604/99.01, 604/70|
|International Classification||A61M5/30, A61M29/00|
|Cooperative Classification||A61M25/1018, A61M5/16881, A61M25/10185, A61M25/104, A61M25/10182, A61M5/14526|
|Dec 26, 2002||AS||Assignment|
Owner name: HARVARD CLINICAL TECHNOLOGY, INC., MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:FLACHBART, ERIC J.;REEL/FRAME:013604/0576
Effective date: 20021219
|Oct 18, 2005||AS||Assignment|
Owner name: HARVARD APPARATUS, INC., MASSACHUSETTS
Free format text: RELEASE BY SECURED PARTY;ASSIGNOR:BROWN BROTHERS HARRIMAN & CO.;REEL/FRAME:016651/0306
Effective date: 20051018
|Nov 21, 2005||AS||Assignment|
Owner name: CARDINAL HEALTH SWITZERLAND 317 S.A.R.L., SWITZERL
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:HARVARD CLINICAL TECHNOLOGY, INC.;REEL/FRAME:017045/0020
Effective date: 20051017
|Aug 26, 2010||FPAY||Fee payment|
Year of fee payment: 4
|Mar 31, 2011||AS||Assignment|
Owner name: CAREFUSION 303, INC., CALIFORNIA
Free format text: CHANGE OF NAME;ASSIGNOR:CARDINAL HEALTH 303, INC.;REEL/FRAME:026067/0550
Effective date: 20090729
|Aug 27, 2014||FPAY||Fee payment|
Year of fee payment: 8